Stress Urinary IncontinenceNCT04133935
Treating Stress Urinary Incontinence: Laparoscopic Obturator Urethropexy vs Burch Urethropexy
A study testing Laparoscopic Obturator Urethropexy and Burch Urethropexy in people with Stress Urinary Incontinence, run by Mount Sinai Hospital, Canada.
Trial summary
Stress urinary incontinence (SUI) is a highly prevalent concern within the female population. Although mid urethral slings (MUS) have been the first line treatment for SUI for almost twenty years, due to recent FDA warnings and many countries banning the use of vaginal mesh, a significant portion of patients now… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Laparoscopic Obturator Urethropexy and Burch Urethropexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 1 Oct 2033
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age and be able to read and write English
- Women with symptomatic SUI, stress predominant mixed urinary incontinence symptoms confirmed on urodynamic study (UDS), or occult SUI (i.e. demonstrable urinary leakage on preoperative urodynamics with prolapse reduction in a patient without overt urinary incontinence symptoms), including women undergoing concomitant pelvic organ prolapse (POP) surgery or MUS sling removal
Who cannot join
- Known or suspected disease that affects bladder function (e.g. multiple sclerosis, Parkinson disease), including a known diagnosis of voiding dysfunction
- Pregnancy
- Desired fertility
- Urethral diverticulum
- History of radical pelvic surgery or pelvic radiation therapy
- Current chemotherapy or radiation therapy for malignancy
About this study
Official title: Prospective Review of Laparoscopic Burch Urethropexy Compared With a Novel Technique of Laparoscopic Obturator Urethropexy: A Randomized Controlled Trial
Stress urinary incontinence (SUI) is a highly prevalent concern within the female population. Although mid urethral slings (MUS) have been the first line treatment for SUI for almost twenty years, due to recent FDA warnings and many countries banning the use of vaginal mesh, a significant portion of patients now request non-mesh anti-incontinence procedures. In such cases, Burch colposuspension would be the next option discussed with patients.
In the short term, the efficacy of Burch colposuspension is comparable to MUS. However, the noteworthy disadvantages of Burch colposuspension include a high rate of urinary retention. This increased risk of urinary retention is due to the acute angle of the stitches, and is a problem that Burch colposuspension shares with the retropubic sling, a type of acutely-angled MUS. A variant of the retropubic sling, the transobturator tape (TOT), has shown that a rounder angle of elevation significantly reduces the risk of urinary retention. As such, this study proposes a novel technique of laparoscopic obturator urethropexy (LOU) as an alternative to the traditional Burch colposuspension.
In this new proposed technique, stitches are placed into the obturator internus fascia rather than Cooper's ligament, reducing the angle of elevation of the bladder neck, aiming to lower the risk of post-operative urinary retention. The aim of our randomized control trial is to assess the effectiveness of LOU compared to Burch colposuspension in terms of urinary continence. Our secondary aim is to report on perioperative and postoperative complications, functional outcomes including urinary retention, recurrent urinary tract infection, recurrent/persistent urgency, de novo urgency, recurrent SUI, and sexual function, as well as overall quality of life.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Laparoscopic Obturator Urethropexy, Burch Urethropexy
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Obturator UrethropexyProcedure or surgery
Suspending the periurethral vaginal tissue to the obturator internus fascia bilaterally via sutures, creating a support for the bladder neck compartment.
Burch UrethropexyProcedure or surgery
Suspending the periurethral vaginal tissue to Cooper's ligament bilaterally via sutures, creating a support for the bladder neck compartment
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Obturator Urethropexy | Experimental | Suspending the periurethral vaginal tissue to the obturator internus fascia bilaterally via sutures, creating a support for the bladder neck compartment Receives: Procedure: Laparoscopic Obturator Urethropexy |
| Burch Urethropexy | Active comparator | Suspending the periurethral vaginal tissue to Cooper's ligament bilaterally via sutures, creating a support for the bladder neck compartment Receives: Procedure: Burch Urethropexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Continence Rates
Patient reported symptoms of incontinence
Measured: 1 year
Secondary outcomes (8)
Objective continence rates
Objective continence rates will be assessed with a cough test and a one-hour pad test.
Measured: 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Perioperative and postoperative complications
Perioperative and postoperative complications will be assessed using the Clavien-Dindo (CD) classification.
Measured: 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Urinary retention
Urinary retention will be assessed by an elevated post-void residual urine
Measured: 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Recurrent urinary tract infection
Recurrent urinary tract infection will be assessed through a urine culture
Measured: 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Recurrent/persistent/de novo urgency
Recurrent/persistent/de novo urgency will be based on patient symptoms
Measured: 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Recurrent SUI
Recurrent SUI will be assessed through a cough test/a one-hour pad test
Measured: 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Sexual function
Using the Female Sexual Function Index-6 (FSFI-6).
Measured: 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Overall quality of life
Using the Pelvic Floor Distress Inventory-20 (PFDI-20).
Measured: 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start1 Jan 2023 (estimated)
- Primary completion1 Jan 2032 (estimated)
- Study completion1 Oct 2033 (estimated)
Why it stopped: Due to COVID restrictions this study has been temporarily halted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded, randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nucelio Luiz de Barros Moreira Lemos MD, PhD, Mount Sinai Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133935
- Sponsor's protocol ID
- 19-0210-A
- Status last verified
- Nov 2021
- First submitted
- 30 Sep 2019
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Review of Laparoscopic Burch Urethropexy Compared With a Novel Technique of Laparoscopic Obturator Urethropexy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04133935
- Acronym / sponsor ID
- 19-0210-A
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to COVID restrictions this study has been temporarily halted.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Jan 2032 (estimated)
- Study completion
- 1 Oct 2033 (estimated)
- First posted
- 21 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stress urinary incontinence (SUI) is a highly prevalent concern within the female population. Although mid urethral slings (MUS) have been the first line treatment for SUI for almost twenty years, due to recent FDA warnings and many countries banning the use of vaginal mesh, a significant portion of patients now request non-mesh anti-incontinence procedures. In such cases, Burch colposuspension would be the next option discussed with patients.
In the short term, the efficacy of Burch colposuspension is comparable to MUS. However, the noteworthy disadvantages of Burch colposuspension include a high rate of urinary retention. This increased risk of urinary retention is due to the acute angle of the stitches, and is a problem that Burch colposuspension shares with the retropubic sling, a type of acutely-angled MUS. A variant of the retropubic sling, the transobturator tape (TOT), has shown that a rounder angle of elevation significantly reduces the risk of urinary retention. As such, this study proposes a novel technique of laparoscopic obturator urethropexy (LOU) as an alternative to the traditional Burch colposuspension.
In this new proposed technique, stitches are placed into the obturator internus fascia rather than Cooper's ligament, reducing the angle of elevation of the bladder neck, aiming to lower the risk of post-operative urinary retention. The aim of our randomized control trial is to assess the effectiveness of LOU compared to Burch colposuspension in terms of urinary continence. Our secondary aim is to report on perioperative and postoperative complications, functional outcomes including urinary retention, recurrent urinary tract infection, recurrent/persistent urgency, de novo urgency, recurrent SUI, and sexual function, as well as overall quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Obturator Urethropexy | Experimental | Procedure: Laparoscopic Obturator UrethropexySuspending the periurethral vaginal tissue to the obturator internus fascia bilaterally via sutures, creating a support for the bladder neck compartment |
| Burch Urethropexy | Active comparator | Procedure: Burch UrethropexySuspending the periurethral vaginal tissue to Cooper's ligament bilaterally via sutures, creating a support for the bladder neck compartment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 18 years of age and be able to read and write English
- Women with symptomatic SUI, stress predominant mixed urinary incontinence symptoms confirmed on urodynamic study (UDS), or occult SUI (i.e. demonstrable urinary leakage on preoperative urodynamics with prolapse reduction in a patient without overt urinary incontinence symptoms), including women undergoing concomitant pelvic organ prolapse (POP) surgery or MUS sling removal
Key exclusion criteria (6 listed)
- Known or suspected disease that affects bladder function (e.g. multiple sclerosis, Parkinson disease), including a known diagnosis of voiding dysfunction
- Pregnancy
- Desired fertility
- Urethral diverticulum
- History of radical pelvic surgery or pelvic radiation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Obturator UrethropexySuspending the periurethral vaginal tissue to the obturator internus fascia bilaterally via sutures, creating a support for the bladder neck compartment. | Procedure or surgery | Laparoscopic Obturator Urethropexy |
| Burch UrethropexySuspending the periurethral vaginal tissue to Cooper's ligament bilaterally via sutures, creating a support for the bladder neck compartment | Procedure or surgery | Burch Urethropexy |
Primary outcome
Subjective Continence Rates
Time frame: 1 year
Patient reported symptoms of incontinence
8 secondary outcomes
Objective continence rates
Time frame: 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Perioperative and postoperative complications
Time frame: 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Urinary retention
Time frame: 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Recurrent urinary tract infection
Time frame: 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Recurrent/persistent/de novo urgency
Time frame: 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Recurrent SUI
Time frame: 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Sexual function
Time frame: 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Overall quality of life
Time frame: 6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Obturator Urethropexy and Burch Urethropexy in people with Stress Urinary Incontinence, run by Mount Sinai Hospital, Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Continence Rates (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.